(73 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML.
Yes.
The device is used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in peripheral vasculature and arteriovenous dialysis fistulae, which is a therapeutic intervention.
No
Explanation: The device is a balloon dilatation catheter used for therapeutic purposes (angioplasty and stent post-dilatation) to treat obstructive lesions, not to diagnose them.
No
The device description clearly details a physical medical device (catheter with a balloon) and includes extensive bench and biocompatibility testing related to the physical properties and performance of the hardware. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature and for the treatment of obstructive lesions. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a balloon catheter designed to be inserted into blood vessels to dilate them. This is an invasive medical device used for treatment.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such tests on samples.
The device is a therapeutic medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Product codes
LIT
Device Description
The Sterling OTW Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is a high performance balloon catheter for peripheral indications. The device features an ultra low profile, semi-compliant balloon combined with a low profile tip. The catheter is compatible with either 0.014 in (.36 mm) or 0.018 in (.46 mm) guidewires.
The Sterling OTW PTA Balloon Dilatation Catheter is an Over-The-Wire (OTW) catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guide wires 0.014 in or 0.018 in (.36 mm or .46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon.
The balloon lengths are available in 120, 150, 200 and 220 mm sizes with diameters of 5.0, 6.0 and 7.0 mm for each balloon length.
The effective lengths of the balloon catheter are 90 cm and 150 cm. Markers on the 90 cm effective length catheter indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 50 cm and two at 60 cm). Markers on the 150 cm effective length catheter indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 90 cm and two at 100 cm). The proximal portion of the catheter includes one female Luer-lock port connected to the inflation lumen, and one female Luer-lock port for guidewire lumen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. The Sterling OTW PTA Balloon Dilatation Catheter met all acceptance criteria for the bench and biocompatibility testing with results similar to the predicate. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices.
The following biocompatibility and bench testing were completed on the Sterling OTW PTA Balloon Dilatation Catheter: Biocompatibility
The device was tested for biocompatibility per ISO 10993-1 for short duration contact with blood (
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
K132430 .p. 1 of 4
510(k) Summary
per 21 CFR §807.92
OCT 1 7 2013
| Submitter's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name
and
Information | Christopher Dachel
Senior Regulatory Affairs Specialist
Phone: 763-494-2718
Fax: 763-494-2222
e-mail: dachelc@bsci.com |
| Date Prepared | 17 October 2013 |
| Proprietary
Name | Sterling™ Over-the-Wire™ (OTW) PTA Balloon Dilatation Catheter |
| Common Name | Percutaneous Catheter |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Classification | Class II, 21 CFR Part 870.1250 - Percutaneous Catheter |
| Predicate
Device(s) | Sterling OTW PTA Balloon Dilatation Catheter, K053116, December 16, 2005 |
| Device
Description | The Sterling OTW Percutaneous Transluminal Angioplasty (PTA) Balloon
Dilatation Catheter is a high performance balloon catheter for peripheral
indications. The device features an ultra low profile, semi-compliant
balloon combined with a low profile tip. The catheter is compatible with
either 0.014 in (.36 mm) or 0.018 in (.46 mm) guidewires.
The Sterling OTW PTA Balloon Dilatation Catheter is an Over-The-Wire
(OTW) catheter with a semi-compliant balloon fixed at the distal tip. The
balloon catheter has a coaxial shaft design. The outer lumen is used for
inflation of the balloon, and the wire lumen permits the use of guide wires
0.014 in or 0.018 in (.36 mm or .46 mm) to facilitate advancement of the
catheter to and through the stenosis to be dilated. The balloon is designed
to provide an inflatable segment of known diameter and length at
recommended pressures. The catheter includes a tapered tip to facilitate
advancement of the catheter to and through the stenosis. Two radiopaque
marker bands (one proximal and one distal), in conjunction with
fluoroscopy, enable accurate positioning of the balloon.
The balloon lengths are available in 120, 150, 200 and 220 mm sizes with
diameters of 5.0, 6.0 and 7.0 mm for each balloon length.
The effective lengths of the balloon catheter are 90 cm and 150 cm.
Markers on the 90 cm effective length catheter indicate the exit of the
dilatation catheter tip out of the guiding catheter (one at 50 cm and two at
60 cm). Markers on the 150 cm effective length catheter indicate the exit of
the dilatation catheter tip out of the guiding catheter (one at 90 cm and two
at 100 cm). The proximal portion of the catheter includes one female Luer-
lock port connected to the inflation lumen, and one female Luer-lock port
for guidewire lumen. |
1
.
| K132430 |
|---|
| p. 2 of 4 |
| Intended Use/
Indications for
Use of Device | The Sterling OTW PTA Balloon Dilatation Catheter is indicated for
Percutaneous Transluminal Angioplasty (PTA) in the peripheral
vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal
arteries, and for the treatment of obstructive lesions of native or synthetic
arteriovenous dialysis fistulae. This device is also indicated for post-
dilatation of balloon expandable and self-expanding stents in the peripheral
vasculature. |
| --------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
·
·
'
2
(
Comparison of Technological Characteristics
The Sterling OTW PTA Balloon Dilatation Catheter will incorporate a substantially equivalent design, packaging, fundamental technology, materials, manufacturing, sterilization and intended use as those featured in the predicate BSC Sterling OTW Balloon Dilatation Catheter.
| Comparison to Predicate Device in Materials and Manufacturing | |
|---|---|
| --------------------------------------------------------------- | -- |
| Characteristic | Comparison to Sterling OTW Predicate |
|---|---|
| Manifold | Same material. Same design serving the same function. |
| Manifold Bond Adhesive | Same material. Same design serving the same function. |
| Strain Relief | Same material. Same design serving the same function. |
| Corewire | Same material. Same design serving the same function. |
| Outer Shaft | Same material. Same design serving the same function. |
| Inner Shaft | Same material. Same colorants. Same design serving the same function. |
| Balloon | Same material. Same design serving the same function and fundamental technology. |
| Markerbands | Same component serving the same function. |
| Proximal Marks | Same material. Same design serving the same function. |
| Coating | Same coating serving same function. |
| Bumper Tip | Same material. Same colorant. Same design serving the same function. |
| Sterilization Method | Same method |
| SAL | Same level of assurance |
| Balloon Diameters | Diameters within the predicate diameter range, service the same function. |
| Balloon Lengths | Additional balloon lengths; 120, 150, 200, and 220 mm |
| Usable Catheter Lengths | Additional catheter lengths; 90 and 150 cm |
| Rated Burst Pressure | |
| (RBP) | Same Rated Burst Pressure |
| Recommended | |
| Introducer Sheath | |
| Compatibility | Sheath compatibility within the predicate compatibility range, same function |
| Recommended | |
| Guidewire | Same compatability |
| Packaging | Same function and design |
3
| Performance
Data | Bench testing and biocompatibility testing were performed to support a
determination of substantial equivalence. The results of these tests provide
reasonable assurance that the proposed device has been designed and
tested to assure conformance to the requirements for its intended use. The
Sterling OTW PTA Balloon Dilatation Catheter met all acceptance criteria
for the bench and biocompatibility testing with results similar to the
predicate. No new safety or performance issues were raised during the
testing and, therefore, these devices may be considered substantially
equivalent to the predicate devices. | | | | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|--|--|--|
| | The following biocompatibility and bench testing were completed on the
Sterling OTW PTA Balloon Dilatation Catheter:
Biocompatibility
The device was tested for biocompatibility per ISO 10993-1 for short
duration contact with blood ( Trade/Device Name: Sterling™ Over-the-Wire™ (OTW) PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: August 22, 2013 Received: August 23, 2013
Dear Mr. Dachel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Mr. Christopher Dachel
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Bram DZuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center_for_Devices_and_Radiological_Health_
Enclosure
6
Indications for Use
510(k) Number (if known): _ K132430
Device Name: Sterling™ Over-the-Wire™ (OTW) PTA Balloon Dilatation Catheter
Indications for Use:
The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bram 2013.1
Boston Scientific Corporation
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